Egfr Mutation Positive Non Small Cell Lung Cancer Therapeutics

1. Gilotrif patent expiration

Treatment: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy; Treatment of cancer

GILOTRIF's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6251912 BOEHRINGER INGELHEIM Substituted quinazoline derivatives
Jul, 2018

(7 years ago)

US8426586 BOEHRINGER INGELHEIM Process for preparing amino crotonyl compounds
Oct, 2029

(3 years from now)

USRE43431 BOEHRINGER INGELHEIM Quinazoline derivatives and pharmaceutical compositions containing them
Jan, 2026

(4 days from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9539258 BOEHRINGER INGELHEIM Quinazoline derivatives for the treatment of cancer diseases
Nov, 2026

(9 months from now)

US8545884 BOEHRINGER INGELHEIM Solid pharmaceutical formulations comprising BIBW 2992
Dec, 2029

(3 years from now)

US10004743 BOEHRINGER INGELHEIM Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Jul, 2030

(4 years from now)

US8545884

(Pediatric)

BOEHRINGER INGELHEIM Solid pharmaceutical formulations comprising BIBW 2992
Jun, 2030

(4 years from now)

US8426586

(Pediatric)

BOEHRINGER INGELHEIM Process for preparing amino crotonyl compounds
Apr, 2030

(4 years from now)

USRE43431

(Pediatric)

BOEHRINGER INGELHEIM Quinazoline derivatives and pharmaceutical compositions containing them
Jul, 2026

(6 months from now)

US10004743

(Pediatric)

BOEHRINGER INGELHEIM Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Jan, 2031

(4 years from now)

US9539258

(Pediatric)

BOEHRINGER INGELHEIM Quinazoline derivatives for the treatment of cancer diseases
May, 2027

(1 year, 3 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 12, 2018
New Indication(I-730) Apr 15, 2019
Orphan Drug Exclusivity(ODE-50) Jul 12, 2020
New Indication(I-763) Jan 12, 2021
Orphan Drug Exclusivity(ODE) Apr 15, 2023
Orphan Drug Exclusivity(ODE-115) Apr 15, 2023
Orphan Drug Exclusivity(ODE-230) Jan 12, 2025
M(M-276) Apr 07, 2025
Pediatric Exclusivity(PED) Oct 07, 2025

Drugs and Companies using AFATINIB DIMALEATE ingredient

NCE-1 date: 07 October, 2024

Market Authorisation Date: 12 July, 2013

Dosage: TABLET

How can I launch a generic of GILOTRIF before it's drug patent expiration?
More Information on Dosage

GILOTRIF family patents

Family Patents

2. Hernexeos patent expiration

Treatment: Use of zongertinib for treating non-small cell lung cancer (nsclc)

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11608343 BOEHRINGER INGELHEIM NA
Jul, 2041

(15 years from now)

US12171739 BOEHRINGER INGELHEIM NA
Nov, 2026

(10 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 08, 2030

Drugs and Companies using ZONGERTINIB ingredient

NCE-1 date: 08 August, 2029

Market Authorisation Date: 08 August, 2025

Dosage: TABLET

More Information on Dosage

HERNEXEOS family patents

Family Patents

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3. Iressa patent expiration

Treatment: Treatment of non-small cell lung cancer; First-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5770599 ASTRAZENECA Quinazoline derivatives
May, 2017

(8 years ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5616582 ASTRAZENECA Quinazoline derivatives as anti-proliferative agents
Jan, 2013

(12 years ago)

US5770599 ASTRAZENECA Quinazoline derivatives
May, 2017

(8 years ago)

US5457105 ASTRAZENECA Quinazoline derivatives useful for treatment of neoplastic disease
Jan, 2013

(12 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jul 13, 2018
Orphan Drug Exclusivity(ODE) Jul 13, 2022
Orphan Drug Exclusivity(ODE-95) Jul 13, 2022

Drugs and Companies using GEFITINIB ingredient

Market Authorisation Date: 13 July, 2015

Dosage: TABLET

More Information on Dosage

IRESSA family patents

Family Patents

4. Lazcluze patent expiration

Treatment: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr exon 19 deletions or exon 21 l858r substitution mutations, in combination with amivantam...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9593098 JANSSEN BIOTECH Compounds and compositions for modulating EGFR mutant kinase activities
Oct, 2035

(9 years from now)

US11453656 JANSSEN BIOTECH Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Apr, 2038

(12 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11981659 JANSSEN BIOTECH Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Apr, 2038

(12 years from now)

US11850248 JANSSEN BIOTECH Therapies with 3rd generation EGFR tyrosine kinase inhibitors
Aug, 2041

(15 years from now)

US11879013 JANSSEN BIOTECH Combination therapies with bispecific anti-EGFR/c-Met antibodies and third generation EGFR tyrosine kinase inhibitors
May, 2040

(14 years from now)

US12138351 JANSSEN BIOTECH Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
Apr, 2041

(15 years from now)

US12318390 JANSSEN BIOTECH NA
Apr, 2038

(12 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 19, 2029

Drugs and Companies using LAZERTINIB MESYLATE ingredient

NCE-1 date: 19 August, 2028

Market Authorisation Date: 19 August, 2024

Dosage: TABLET

More Information on Dosage

LAZCLUZE family patents

Family Patents

5. Tarceva patent expiration

Treatment: Treatment of locally advanced or metastatic non small-cell lung cancer (nsclc) after failure of at least one prior chemotherapy regimen; Maintenance treatment in patients with locally advanced or meta...

TARCEVA IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE41065 OSI PHARMS Alkynl and azido-substituted 4-anilinoquinazolines
Nov, 2018

(7 years ago)

US5747498 OSI PHARMS Alkynyl and azido-substituted 4-anilinoquinazolines
Nov, 2018

(7 years ago)

US7087613 OSI PHARMS Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
Nov, 2020

(5 years ago)

US6900221

(Pediatric)

OSI PHARMS Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof
May, 2021

(4 years ago)

US7087613

(Pediatric)

OSI PHARMS Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
May, 2021

(4 years ago)

US6900221 OSI PHARMS Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof
Nov, 2020

(5 years ago)

US5747498

(Pediatric)

OSI PHARMS Alkynyl and azido-substituted 4-anilinoquinazolines
May, 2019

(6 years ago)

USRE41065

(Pediatric)

OSI PHARMS Alkynl and azido-substituted 4-anilinoquinazolines
May, 2019

(6 years ago)




Drug Exclusivity Drug Exclusivity Expiration
M(M-79) Sep 19, 2011
New Indication(I-624) Apr 16, 2013
New Indication(I-671) May 14, 2016
Pediatric Exclusivity(PED) Nov 14, 2016
New Dosing Schedule(D-164) May 20, 2019
M(M-181) Jun 01, 2019
M(M-190) Oct 18, 2019

Drugs and Companies using ERLOTINIB HYDROCHLORIDE ingredient

Market Authorisation Date: 18 November, 2004

Dosage: TABLET

How can I launch a generic of TARCEVA before it's drug patent expiration?
More Information on Dosage

TARCEVA family patents

Family Patents